Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chinese PLA General Hospital
Sponsor:
Collaborator:
Navy General Hospital, Beijing
Information provided by (Responsible Party):
Li Yu, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01690507
First received: September 19, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.


Condition Intervention Phase
MDS
AML
Drug: Decitabine
Drug: Cytarabine
Drug: aclacinomycin
Drug: Granulocyte colony-stimulating factor
Other: HLA haploidentical mononuclear cells infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML)

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • event free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCAG plus DLI
Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion
Drug: Decitabine
20 mg/m²/day for 5 days
Drug: Cytarabine Drug: aclacinomycin Drug: Granulocyte colony-stimulating factor
Other Name: G-CSF
Other: HLA haploidentical mononuclear cells infusion
Other Name: DLI
Active Comparator: DCAG
Patients will be treated with decitabine and modified CAG regimen
Drug: Decitabine
20 mg/m²/day for 5 days
Drug: Cytarabine Drug: aclacinomycin Drug: Granulocyte colony-stimulating factor
Other Name: G-CSF

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PATIENT Inclusion Criteria:

  • Must have a diagnosis of MDS-RAEB or AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies
  • Must have life expectancy >= 3 months
  • Must have the ability to observe the efficacy and events
  • Must have no accompany therapy(including steroid)
  • Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3
  • Must have haploidentical donor

DONOR Inclusion Criteria:

  • Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required
  • Both men and women and members of all races and ethnic groups are eligible for this trial

PATIENT Exclusion Criteria:

  • Must not have an advanced malignant hepatic tumor
  • Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
  • Must not be receiving any other investigational agents within 14 days of first dose of study drug
  • Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
  • Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
  • Must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study
  • Must not have a known or suspected hypersensitivity to decitabine
  • Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with decitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

DONOR Exclusion Criteria:

  • Must not have any underlying conditions which would contra-indicate apheresis
  • Must not be pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690507

Contacts
Contact: Li Yu, M.D. Ph.D. 86-010-55499003 chunhuiliyu@yahoo.com
Contact: Li-Xin Wang, M.D. Ph.D. 86-010-66958509 wanglixin1991@sohu.com

Locations
China, Beijing
Navy General Hospital Recruiting
Beijing, Beijing, China, 100048
Contact: Li-Xin Wang, M.D Ph.D    86-010-66958509    wanglixin1991@sohu.com   
Principal Investigator: Li-Xin Wang, M.D. Ph.D.         
China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Li Yu, M.D. Ph.D.    86-010-55499003    chunhuiliyu@yahoo.com   
Principal Investigator: Li Yu, M.D. Ph.D.         
Sponsors and Collaborators
Chinese PLA General Hospital
Navy General Hospital, Beijing
Investigators
Principal Investigator: Li Yu, M.D. Ph.D. Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Li Yu, Director of Department of Hematology and BMT Center, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01690507     History of Changes
Other Study ID Numbers: CN301-XYK-001
Study First Received: September 19, 2012
Last Updated: January 30, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
demethylating agent
immunogenicity

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Decitabine
Aclacinomycins
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Adjuvants, Immunologic
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 29, 2014